This Manual is written and compiled in accordance with the council
Contents
1. A The device has the function of limits alarming when the measured data is beyond the highest or lowest limit the device would start alarming automatically on the premise of the alarming function 1s on A The device has the function of alarming this function can either be paused or closed for good please check the chapter 6 1 as a reference A The device may not work for all patients If you are unable to achieve stable readings discontinue use 2 Overview The pulse oxygen saturation is the percentage of HbO in the total Hb in the blood so called the O2 concentration in the blood It is an important bio parameter for the respiration A number of diseases relating to respiratory system may cause the decrease of SpO gt in the blood furthermore some other causes such as the malfunction of human body s self adjustment damages during surgery and the injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in human body and the corresponding symptoms would appear as a consequence such as vertigo impotence vomit etc Serious symptoms might bring danger to human s life Therefore prompt information of patients SpO gt is of great help for the doctor to discover the potential danger and is of great importance in the clinical medical field The Pulse Oximeter features in small volume convenient operation and being portable It is only necessary for patients to put one of his fingers into a probe for diagno2. exit the Figurel0 and perform setting YES for stopping recording NO for continue recording Figure 10 d If the data storage function is being turned on when return to the measuring interface a red REC sign and a flashing red dot would appear on screen which means the device 1s in a state of storing e In the state of storing whatever interface the device is on measuring interface menu interface the sign Recording would appear on the screen in 30 seconds and then the screen will be automatically shut down If pressing any button power on off excluded at this moment the sign Recording would appear on the screen and then the screen will be automatically shut down again if pressing the power on off button the device would return to the former interface f If turning on the data storage function the former data storage will be automatically removed g In the state of data storing after the screen is automatically shut down the pulse sound indication would be off for saving power h When the storage space is full it displays Memory is full on the screen and then shut down in a few seconds But it will still display Memory is full by the next time you turn on the device on the purpose of warning the user if press any button power on off excluded again it will enter the measuring interface e Stored data transmission setting Firstly please install the affiliated software into the computer and then
3. gt The oximeter cannot be used together with devices not specified in User s Manual Only the accessory that appointed or recommendatory by manufacture can be used with this device lt gt This product is calibrated before leaving factory 1 2 Warning Explosive hazard DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic agents 6 DO NOT use the oximeter while the testee measured by MRI and CT The person who is allergic to rubber can not use this device The disposal of scrap instrument and its accessories and packings including battery plastic bags foams and paper boxes should follow the local laws and regulations Please check the packing before use to make sure the device and accessories are totally in accordance with the packing list or else the device may have the possibility of working abnormally Please choose the accessories and probe which are approved or manufactured by the manufacturer or else it may damage the device The device can only be matched with the compatible probe Please don t measure this device with function test paper for the device s related information 1 3 Attention A Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture A Ifthe oximeter gets wet please stop operating it A When it is carried from cold environment to warm or humid environment please do not
4. into the probe Refer to Figure 4 b Press the power on off button long until the device turns on c Do not shake the finger and keep the patient in a stable state during the process d The data can be read directly from the screen on the measuring interface A Fingernails and the luminescent tube should be on the same side A If the alarm function is on the device will provide midium priority alarm signal when probe or finger is out and intermittent alarm will occur Figure4 Actual probe may be different with the probe as figure 4 please accept the actual probe with the device B Pause alarm a Alarm including the alarm of measure data s going beyond the limits the alarm of low voltage the alarm of probe or finger s out of position b When alarm is on press the alarm pause button can pause the alarm it can renew alarm in about 60s and if pressing the alarm pause button Again with in 60s 1t can renew alarm c Ifyou want to turn off the alarm for good you should enter the menu for operation C Review Interface a On the measuring interface press up button to enter the Review Interface 1 directly as shown in figureS Figure5 Review Interface 1 b In review interface press menu button to switch between Review Interface 1 and Review Interface 2 press Down button to enter the review interface for next hour or last hour In Review Interface 1 press left button or right button can move
5. two icons would appear on the desktop after installation The icon of SpO2 is a program for receiving real time data which is shown as figure 11 the icon of SpO2 Review is a program for receiving stored data which 1s shown Y apis as figure 12 Figure 11 SpO2 program ie alas Figure 12 SpO2 Review program a Please connect the device with computer by the data line which 1s affiliated with the device then double click SpO Review icon to open SpO Review program click the New Session Icon in the software enter the patient data and then click ok The Software will then display device connected waiting for data b On the main menu interface press the up button or down button to select Upload Press the left button or right button to select on then the data will be transferred to your computer c In the state of storing it 1s not applicable for the users to upload the stored date to computer d When the stored data is being uploaded ON will be shown behind the upload item e When the upload of stored data is finished OFF will be shown behind the upload item f Exit the main menu On the main menu interface press the menu button to exit the main menu E Real time data transmission a Please connect the device with computer by the data line which is equipped with the device then double click SpO2 icon to open SpO2 program b The data can be displayed on computer screen in a few seconds
6. would sincerely regret for that This product is medical device which can be used repeatedly WARNING Uncomfortable or painful feeling may appear if using the device ceaselessly especially for the microcirculation barrier patients It is recommended that the sensor should not be applied to the same finger for over 2 hours For the special patients there should be a more prudent inspecting in the placing process The device can not be clipped on the edema and tender tissue The light the infrared is invisible emitted from the device is harmful to the eyes so the user and the maintenance man should not stare at the light Testee can not use enamel or other makeup 6 Testee s fingernail can not be too long Please refer to the correlative literature about the clinical restrictions and caution This device is not intended for treatment The User Manual is published by our company All rights reserved II Contents ESAFE TN 1 I MAS tHUCHONS 1OF Sale O A dE o l A E II l We EAEE ET e a EE EE EE AT ATTE EN EAE E ITE A E TE EE OET AA I EOI A E NA TOA l ZOVERVIE W sisi di id lidad 2 O 2 2 2 Major applications and scope of application dai 2 2 Environment regii remets 8a ata A SS 3 JERINCIPLE ia 3 ATECHNICAL SPE CIBICA TON Sis ne 3 AI arene ere ern enone ee Non Onn orm npr nner Gra One ROP A HEMET Ora One RUPEES Re tre wren 3 AL NA EAL ALC A A 4 INSTALLATION cansino censucsecseatuescatescss
7. O 1 Pulse rate I bpm D Measurement Performance in Weak Filling Condition SpO and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO error is 4 pulse rate error is 2 bpm or 2 select larger E Resistance to surrounding light The deviation between the value measured in the condition of man made light or indoor natural light and that of darkroom is less than 1 F Power supply requirement 2 2 V DC 3 6V DC G Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW 5 Installation 5 1 View of the front panel Figure 2 Front View 5 2 Battery and probe installation A Refer to Figure 3 and insert the two AA size batteries properly in the right direction 3 2 Figure 3 batteries installation B Replace the cover C Inserting the SpO gt probe of the pulse oximeter in the upper jack The probe is limited to be produced by our company never replace it with the similar ones by other manufacturers A Please take care when you insert the batteries for the improper insertion may damage the device If the alarm function is on the device will provide high priority alarm signal when the battery is in low power status and intermittent alarm will occur 5 3 Accessories A Dry battery 2AA B A User Manual C A data line D A disk PC software E An oximeter probe 6 Operating Guide 6 1 Application method A a Put the finger
8. c When you unplug the data line from computer there is a dialog box Save data at view appearing on the desktop in which you can input some patient s basic information 6 2 Attention for operation A Please check the device before using and confirm that it can work normally B The finger should be in a proper position see the attached illustration of figure 4 for reference or else it may result in inaccurate measure C The SpO sensor and photoelectric receiving tube should be arranged in a way with the subject s arteriole in a position there between D The SpO sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection E Do not fix the SpO sensor with adhesive or else it may result in venous pulsation and inaccurate measure of SpO and pulse rate F Excessive ambient light may affect the measuring result It includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc G Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy H Testee can not use enamel or other makeup I Please clean and disinfect the device after operating according to the User Manual 7 1 10 6 3 Clinical restrictions A As the measure is taken on the basis of arteriole pulse substantial pulsating blood flow of subject 1s required For a subject with weak pulse due to shock low ambient body temperat
9. enssbuencesvacdass ovnivasa sae cesen cairo cli cacao caia 4 Doles VIC WOE LIS THOM TPAS accom ci eased aaa Gade nda 4 5 2 Baten ANG probe 1S CaM AiO 45257 ascii A A Ns 4 DSCC SSO LIES PREIS OE REE ESE E A doatia ayaa tee Mane etn Geatuteeh neue 5 GOPERATING GUIDE cissisccsccecisccevesssssicccsdevacctussacaceuesvacatsevaactdeasstusehicsssdessssdessssseeudevasctsasicaseles OES aar aN 5 oy evan 0 0 1 6r 18 01 11 MeO eomaemne steer mento E A TOES ree ee 5 62 AMENA TOL OP CPA iaa 10 O Clica resti EONS oia 11 7 MAINTAIN TRANSPORTATION AND STORAGE sssssccccccccccesesesssssscooccoceseceessssssssssssseseseee 11 FASC ledning and TDS ATS CIN A is 11 TL A NS 11 Teo Tran Spora oran tota dia pis 11 S TROUBLE SHOOTIN unidad A A A a aa 11 KEY OF SYMBOLS secc tnp a n aaee Oar a e a r 12 TO FUNCTION SPECIEICA TION issiscsscctuccvavcissssacsedesascssdessucdaudevescisssssanssesvisssdacssssesaacevevsiasesdevaseadsedees 13 MI 1 Safety 1 1 Instructions for safe operations lt gt Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient s safety and monitoring performance about cables and transducers It is recommended that the device should be inspected once a week at least When there is obvious damage stop using the device lt gt Necessary maintenance must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themselves lt
10. is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning amp Recording Technology so that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger type sensor Then measured signal can be obtained by a photosensitive element information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor Glow and Infrared ay Emission Tube Glow and Infrared ray e Receipt Tube Figure 1 4 Technical specifications 4 1 Main performance A SpQ value display B Pulse rate value display bar graph display C Pulse waveform display D Low voltage indication low voltage indicator appears before working abnormally which is due to low voltage E Screen brightness can be changed F A pulse sound indication G With alarm function H With SpO value and pulse rate value of storage the stored data can be uploaded to computers I It can be connected with an external oximeter probe J Real time data can be transmitted to computers K Review function 4 2 Main Parameters A Measurement of SpO Measuring range 0 100 Accuracy When the SpO measuring range is 70 100 the permission of absolute error is 2 below 70 unspecified B Measurement of pulse rate Measuring range 25bpm 250bpm Accuracy 2 bpm or 2 select larger C Resolution Sp
11. l inadequacy indicator IPX1 Ingress of liquids rank H WEEE 2002 96 EC E 10 Function Specification Information Display Mode The Pulse Oxygen Saturation SpO gt 2 digit digital OLED display 3 digit digital OLED display Accuracy 2bpm or 2 select larger Safety Type Interior Battery B F Type Pulse Intensity Continuous bar graph display the higher display indicate the stronger pulse 13 Battery Requirement Dry batteryQAA Dimensions and Weight Dimensions 110 x 60 W x 23 H mm About 180g with Dry battery 2AA gt CONTEC SOUTHEASTERN MEDICAL SUPPLY INC Address 1024 Wildwood Centre Dr Ste A Columbia SC 29229 Tel 803 233 3691 Fax 803 233 6140 E mail inquiriestVdsemedicalsupply com
12. on to select Brightness then press the left button or right button to change the number in order to adjust the brightness of screen d Data storage setting This device has the ability to store 24 hours worth of data It can store the measured pulse rate and SpO gt value accurately transfer the data to the computer display the data and print reports with the included SpO Software Green Heart a On the main menu interface press the up button or down button to select Record then press the left button or right button again to enter the dialog box of figure 9 or finger 10 1f 1t 1s not in recording state will come into figure 9 1f it is in recording state will come intofigure 10 Figure 9 b In the status shown in Figure 9 press up button or down button can change the position of selection bar choose the item to be setted press left button or right button can change the setting of the item then press menu button to exit the status in Figure 9 and perform setting Notice when choose NO not recording press up button or down button the selection bar cannot be moved when choose YES recording the selection bar can be moved and set the starting time of record After finish setting press menu button to exit the status in Figure 9 or the equipment cannot perform the recording function c In the status shown in Figurel0 press left button or right button can change the setting press menu button will
13. sis and a display screen will directly show the measured value of pulse oxygen saturation with the high veracity and repetition 2 1 Features A Operation of the product is simple and convenient B The product is small in volume light in weight and convenient in carrying 2 2 Major applications and scope of application The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through finger The product 1s suitable for being used in family hospital oxygen bar community healthcare physical care in sports It can be used before or after doing sports and it is not recommended to use the device during the process of having sport and etc Z N the problem of overrating would emerge when the patient is suffering from toxicosis which caused by carbon monoxide the device is not recommended to be used under this circumstance 2 3 Environment requirements Storage Environment a Temperature 40 60 b Relative humidity 5 95 c Atmospheric pressure 500hPa 1060hPa Operating Environment a Temperature 0 50 b Relative Humidity 15 95 c Atmospheric pressure 700hPa 1060hPa 3 Principle Principle of the Oximeter is as follows An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin Hb and Oxyhemoglobin HbO in glow amp near infrared zones Operation principle of the device
14. smission with the use of data line the specific method is as follows Figure 7 Main Menu Interface a Alarm setting On the main menu interface press the up button or down button to select Alarm then press the left button or right button to enter the alarm setting menu of figure 8 Figure 8 Alarm Setting Menu a The highest lowest alarm limit setting Press the up button or down button to choose the parameter to be adjusted then press the left button or right button to change data Each press of the left button or right button the data will raise or descend for one time accordingly Au the alarm function is on the device will provide midium priority alarm signal when the data of SpO or pulse rate is beyond the limit and intermittent alarm will occur b The alarm state setting Press the up button or down button to select Alarm then choose the alarm state on off by pressing the left button or right button choose on to turn on the alarms and choose off to turn off the alarms for good c Exit the Alarm settings Press the menu button to exit the Alarm Settings Menu b Pulse sound indication setting On the main menu interface press the up button or down button to select Pulse Sound then Press the left button Or right button to choose to have the Pulse Sound heart beat on or off c Backlight adjustment On the main menu interface press the up button or down butt
15. the trend graph for storage data When the trend graph cannot be moved any more the sign lt or gt shown under the LCD screen will disappear in Review Interface 2 press left button or right button can move the arrow Press up button to exit the review Interface c In Review Interface 1 can observe the trend waveform composed by storage data each screen can show storage data for 114 seconds the yellow line shows the SpO trend waveform the red line shows the PR trend waveform the time underside shows the starting time of dispalying the date in mony the screen the middle an underside the screen means the operation direction of the Down button Press right button it will show in the position then press Down button to enter next n hour Press left button it will show in the position then press Down button to enter last hour d The Review Interface 2 shown based on Review Interface 1 the stored SpO value and PR value in each second can be observed here the underside date from left to right marks time SpO value PR value when the stored data exceeds the upper and lower limit setted by user the relevant value will turn green Figure6 Review Interface 2 D Menu operations On the measuring interface press the menu button can enter the menu of figure 7 Users can adjust the settings through the main menu such as alarm pulse sound indication backlight data storage data tran
16. ure major bleeding or use of vascular contracting drug the SpO waveform PLETH will decrease In this case the measurement will be more sensitive to interference B For those with a substantial amount of staining dilution drug such as methylene blue indigo green and acid indigo blue or carbon monoxide hemoglobin COHb or methionine Me Hb or thiosalicylic hemoglobin and some with icterus problem the SpO determination by this monitor may be inaccurate C The drugs like dopamine procaine prilocaine lidocaine and butacaine may also be a major factor blamed for serious error of SpO 2 measure D As the SpO value serves as a reference value for judgement of anemic anoxia and toxic anoxia some patients with serious anemia may also report good SpO measurement 7 Maintain transportation and storage 7 1 Cleaning and Disinfecting Using medical alcohol to disinfect the device nature dry or clean it with clean soft cloth 7 2 Maintain A Please clean and disinfect the device before using according to the User Manual 7 1 B Please change the battery when the screen shows Emmm C Take out the battery if leave the equipment unused for long time C The device needs to be calibrated once a year or according to the calibrating program of hospital It also can be performed at the state appointed agent or just contact us for calibration 7 3 Transportation and storage A The packed device can be transported by ordinary conve
17. use it immediately A DO NOT operate keys on front panel with sharp materials A High temperature or high pressure steam disinfection of the oximeter is not permitted Refer to User Manual in the relative chapter 7 1 for instructions of cleaning and disinfection A Do not have the oximeter immerged in liquid When it needs cleaning please wipe its surface with medical alcohol by soft material Do not spray any liquid on the device directly A When cleaning the device with water the temperature should be lower than 60 A As to the fingers which are too thin or too cold it would probably affect the normal measure of the patients SpO and pulse rate please clip the thick finger such as thumb and middle finger deeply enought into the probe A Whether the device is used to adult or infant it depends on the probe selected A The update period of data is less than 5 seconds which is changeable according to different individual pulse rate A Please read the measured value when the waveform on screen is equably and steady going This measured value is optimal value And the waveform at the moment is the standard one A If some abnormal conditions appear on the screen during test process pull out the finger and reinsert to restore normal use A The device has normal useful life for three years since the first electrified use A This device has the function of alarming users can check on this function according to chapter 6 1 as a reference
18. x Pulse Oximeter User Manual A SOUTHEASTERN MEDICAL SUPPLY INC Instructions to User Dear users thank you very much for purchasing the Pulse Oximeter This Manual is written and compiled in accordance with the council directive MDD93 42 EEC for medical devices and harmonized standards In case of modifications and software upgrades the information contained in this document is subject to change without notice The Manual describes in accordance with the Pulse Oximeter s features and requirements main structure functions specifications correct methods for transportation installation usage operation repair maintenance and storage etc as well as the safety procedures to protect both the user and equipment Refer to the respective chapters for details Please read the User Manual carefully before using this product The User Manual which describes the operating procedures should be followed strictly Failure to follow the User Manual may cause measuring abnormality equipment damage and human injury The manufacturer is NOT responsible for the safety reliability and performance issues and any monitoring abnormality human injury and equipment damage due to users negligence of the operation instructions The manufacturer s warranty service does not cover such faults Owing to the forthcoming renovation the specific products you received may not be totally in accordance with the description of this User Manual We
19. yance or according to transport contract The device can not be transported mixed with toxic harmful corrosive material B The packed device should be stored in room with no corrosive gases and good ventilation Temperature 40 C 60 C Humidity lt 95 8 Troubleshooting 1 Place the finger properly and The SpO and Pulse 1 The finger is not properly positioned try again Rate can not be 2 The patient s SpO is too low to be 2 Try again Go to a hospital for displayed normally detected a diagnosis if you are sure the device works all right 11 1 The finger is not placed inside deep The SpO and Pulse h 1 Place the finger properly and enough Rate are not j _ try again 2 The finger is shaking or the patient is displayed stably 2 Let the patient keep calm moving 1 The battery is drained away or almost 1 Please change batteries The device can not drained away 2 Please Install the battery again be turned on 2 The battery is installed incorrectly 3 Please contact the local service 3 The malfunction of the device center The display is off The battery is drained away or almost l Please change batteries suddenly drained away 9 Key of Symbols E a e 3 Power on off button Ye left button Alarm pause button Menu button OO y ee 12 FR d in Up button Serial number SN 1 the finger clip falls off no finger inserted 2 Probe error 3 Signa
Download Pdf Manuals
Related Search